Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of morab-022 in healthy and rheumatoid arthritis subjects

Conditions: Rheumatoid Arthritis

Summary: this is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study in healthy male and or female subjects and subjects with rheumatoid arthritis (ra) to determine the safety and tolerability of morab-022.


Eligibility criteria:
inclusion criteria for rheumatoid arthritis (ra) subjects: * male or female subjects age greater than or equal to 18 years and less than or equal to 75 years. * subjects with ra diagnosis per the 2010 rheumatoid arthritis classification criteria per american college of rheumatology (acr)/european league against rheumatism (eular.) * bmi less than or equal to 35 kg/m2 at screening. * active ra characterized by das28 score of less than or equal to 5.1 at screening. * have been stabilized on their current dose (up to 25 mg/week) of methotrexate(mtx) for at least 4 weeks before randomization. exclusion criteria for rheumatoid arthritis (ra)subjects: * subjects with severe active ra and are not on a stable therapeutic regimen at screening. * subjects without significant articular ra. * relevant history of significant respiratory disease (e.g., chronic bronchitis, asthma in last 5 years, chronic obstructive pulmonary disease, tuberculosis, interstitial lung disease, such as pneumonitis and pulmonary alveolar proteinosis, as well as significant inhalation exposure to silicon and other substances) that required treatment and/or follow up under the direction of a physician. * presence of gm-csf autoantibodies above normal at screening. * abnormal chest x-ray or pfts as judged by the investigator at screening as clinically significant. * positive quantiferon test. * history of clinically relevant hypersensitivity reactions (e.g., to gold therapy) * history of medication use that might have carryover effects during the study. * previous administration of a gm-csf modulator within 6 months of randomization, or previous administration of a monoclonal antibody or immunoglobulin fusion protein that is not (or worded as "other than") a gm-csf modulator within 3 months of randomization. * use of any biological therapy other than the test article during the study (informed consent to termination visit) * subjects who consume greater than 14 alcoholic drinks per week for males or 7 alcoholic drinks per week for females. * weight greater than 120 kg at screening. * use of parenteral and/or intra-articular steroids, immunosuppressants, investigational drugs, and oral anticoagulant drugs within 4 weeks prior to randomization. oral steroid treatment is permitted if the dosage is less than or equal to 10 mg of prednisone daily, is stable for a minimum of 4 weeks before the study and remains unchanged throughout the study.
methadone versus placebo in spine fusion

Conditions: Postoperative Pain

Summary: what is the influence of methadone on postoperative analgesia after lumbar interbody fusion in opioid naïve patients or patients who are taking less than equivalent of 15 mg iv morphine each day? what is the incidence of opioid related postoperative side effects after the administration of methadone in the operating room?

hypothesis: 1. we hypothesize that 0.2 mg/kg of methadone will result in decreased postoperative hydromorphone consumption compared to hydromorphone alone in opioid naïve patients or patients who are taking less than the equivalent of 15 mg iv morphine a day undergoing lumbar interbody fusion. 2. we hypothesize that the incidence of opioid related postoperative side effects will not be increased by the administration of methadone in the operating room.

Eligibility criteria:
inclusion criteria: * asa physical status i, ii, and iii, male and non-pregnant female * english-speaking patients * ages 18-75 years * undergoing elective one or two level posterior lumbar interbody fusion exclusion criteria: * use of more than the equivalent of 15 mg of iv morphine/24 hr in the past 2 weeks. * use of drugs within the past 6 months that effect the pharmacokinetics or pharmacodynamics of opioids (i.e., benzodiazepines, anti-retroviral agents, rifampin, ketoconazole, erythromycin, or phenytoin). * history of substance abuse at any time in the past * known qt prolongation * non-elective operations (i.e., cancer or trauma) * severe hepatic impairment (serum albumin \< 3.0 g/dl in the presence of a history of liver disease) * pregnancy * inability to operate a patient-controlled analgesia device

Keywords: hydromorphone lumbar posterior spinal fusion lumbosacral spondylosis spinal fusion
topical aluminium chloride vs onabotulinumtoxina intradermal injections in residual limb hyperhidrosis (lower limbs)

Conditions: Hyperhidrosis; Residual Limbs

Summary: the aim of this study is to demonstrate onabotulinumtoxina superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.

after randomization patients will receive either onabotulinumtoxina once or topical aluminium chloride for 6 months. all patients will be evaluated during 3 study visits (week 4, week 12, week 24) and 1 phone call (week 18).

Eligibility criteria:
inclusion criteria: * lower limb amputees suffering from residual limb hyperhidrosis with important cutaneous, functional, social and professional consequences, whatever the amputation cause * hdss ≥ 2 (hyperhidrosis disease severity score) * men and women * 18 to 75 years old * written informed consent * no exclusion criteria * social assurance exclusion criteria: * botulinum toxin injection necessity for another disease * evolutive central neurologic disease or myasthenia. * egg or albumine allergy * botulinum toxin or other excipients hypersensibility * legally protected adults and people unable to give an informed consent. (article l-1121-8 from public health code), people without freedom and people hospitalized without consent (article l-1121-6 from public health code) * pregnant women or giving breast women (article l-1121-5 from public health) * patient refusing participating * previous hyperhidrosis treatment with aluminium chloride in the last 4 weeks * previous hyperhidrosis treatment with botulinum toxin in the last 2 years * other ongoing hyperhidrosis treatment * large residual limb eczematiform lesions: corticoids treatment (for example: locapred® 1 application per day during 1 week then decrease). * aminoglycoside ongoing treatment
safety study of amg 386 to treat her2-positive locally recurrent or metastatic breast cancer

Conditions: Breast Cancer; Breast Neoplasms; Breast Tumors; Cancer; Locally Recurrent and Metastatic Breast Cancer; Metastases; Metastatic Cancer; Oncology; Solid Tumors; Tumors

Summary: the purpose of this study is to determine if amg 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with her2-positive locally recurrent or metastatic breast cancer. this is an open-label phase 1b trial and has 2 study parts. study part 1 is a dose escalation study to determine a tolerable dose of amg 386 in combination with paclitaxel and trastuzumab (cohort a) or with capecitabine and lapatinib (cohort b). study part 2 is cohort expansion of the tolerable doses determined in part 1.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease not amenable to any local treatment with curative intent. * her2-positive by fish, cish, or ihc 3+ * ecog performance status 0 or 1 * left ventricular ejection fraction greater than or equal to institutional lower limit of normal * adequate laboratory studies (hematological, chemistries and urinalysis) * life expectancy greater than or equal to 3 months * cohort a only: * trastuzumab naïve or trastuzumab in the neo-adjuvant setting * no clinically significant drop in cardiac function prior exposure to trastuzumab * no prior chemotherapy for metastatic or locally recurrent breast cancer * no prior lapatinib therapy * at least 3 weeks from enrollment since prior chemotherapeutic agents, including taxanes, in the neoadjuvant or adjuvant setting * at least 3 months from enrollment since prior trastuzumab in the neoadjuvant or adjuvant setting * cohort b only: * must have failed trastuzumab in the first-line metastatic setting. trastuzumab must be discontinued for at least 3 weeks prior to enrollment * must have received prior chemotherapy as adjuvant therapy or for metastatic disease * prior chemotherapy treatment must be discontinued for at least 3 weeks prior to enrollment * no prior capecitabine * no prior lapatinib exclusion criteria: * inflammatory breast cancer * central nervous system metastasis * clinically significant cardiovascular disease * radiation therapy ≤ 14 days prior to enrollment. * concurrent anticoagulation therapy, excluding aspirin, anti-platelet agents, low molecular weight heparin or low dose warfarin per protocol. * uncontrolled hypertension defined as diastolic blood pressure \> 90 mmhg or systolic blood pressure \> 140 mmhg. * subjects with a history of prior malignancy, except: * for cohort b only: * current or prior history of long qt syndrome * baseline ecg report of qtc interval of \> 480 milliseconds * severe chronic liver disease (child pugh c)

Keywords: amg 386 paclitaxel trastuzumab capecitabine lapatinib her2-positive metastatic breast cancer locally recurrent breast cancer taxol herceptin xeloda tykerb anti-angiogenic therapy
improvement of reproductive function in men with spinal cord injury (sci)

Conditions: Infertility, Male

Summary: this is a study of infertility which often occurs in men with spinal cord injury. most men with spinal cord injury have a normal sperm count but abnormally low sperm motility - which means that the sperm does not swim well. this study will determine if a medicine given by mouth will improve sperm motility in men with spinal cord injuries. the medicine is called probenecid.


Eligibility criteria:
inclusion criteria: 1. subject has a traumatic spinal cord injury. 2. subject is male and is 18 years or older. exclusion criteria: 1. subject has been injured less than 1 year. 2. the subject is known to be azoospermic. 3. the subject has an indwelling urethral foley catheter. 4. subject is under the age of 18 years. 5. subject has an unstable medical condition including, but not limited to, crohn's disease, ulcerative colitis, colon cancer or has other conditions deemed to be exclusionary per the investigator. 6. subject is unable to consent or comprehend the procedures and their implications. 7. subject has a permanent implanted electrical device, i.e., cardiac pacemaker, phrenic nerve stimulator, spinal cord stimulator, etc. 8. any subject for whom the procedure or medication is otherwise contraindicated. 9. subject has hypersensitivity to probenecid. 10. subject has a history of uric acid kidney stones and/or peptic ulcer. 11. the subject has had a febrile urinary tract infection (uti) within the 2 months prior to enrollment. 12. the subject is taking methotrexate, aspirin, other salicylates, or anti-inflammatory medicines. 13. the subject has a history of glucose-6-phosphate dehydrogenase (g6pd) deficiency.

Keywords: spinal cord injury
guided self-determination - promoting self-management in type 1 diabetes

Conditions: Diabetes

Summary: background: 50% of people with diabetes are living with too high blood sugars and increased risk of diabetes related complications together with poor quality of life. the need to improve diabetes care by better enabling patients to utilise their individual and local resources to self-manage the condition is widely recognized, yet there is a lack of access to evidence-based patient-centred healthcare interventions. at present the individual patient's judgement of own concrete situation mostly remains unexplored and insufficiently used in decision-making causing that problems perceived by the patient in living with the illness remain unrecognised and insufficiently resolved. aim and methods: guided self-determination (gsd) is an educational method developed to promote patient autonomy, participation, skills building and intrinsic motivation. in this evidence-based group-intervention the main objective is to implement and evaluate gsd through a randomised controlled trial. gsd methods will be performed seven times for the intervention group. the control group will receive traditional out-patient consultations - 'care as usual' outcome measures will be performed at baseline, after 9 and 18 months. the project will focus on adults with type 1 diabetes (18-55 yrs) where an improvement will be highly cost-effective in preventing late complications and enhanced psychosocial health. gsd is presumably an intervention providing psychosocial support applicable in busy clinical practice. an alliance is established between haukeland university hospital, norway and steno diabetes centre, copenhagen, denmark, centre of evidence-based practice, bergen university college, and bergen university to conduct this intervention and thus make the best possible use of interrelated knowledge within the issue.


Eligibility criteria:
inclusion criteria: diabetes type one, hba1c \>= 8% exclusion criteria: pregnancy, decreased cognitive function and/or serious mental health disturbances, language barriers to the norwegian language

Keywords: self management diabetes type one empowerment intrinsic motivation
the study of polycystic ovary syndrome(pcos) with gene and questionnaire

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is an extremely common disorder in women of reproductive age. diagnosis of pcos is principally based on clinical and physical findings. diagnostic criteria and pcos definitions used by clinicians and researchers are almost as heterogeneous as the syndrome. this first part of study is determine whether genetic polymorphisms influence hormonal and metabolic characteristics in taiwanese patients with pcos and controls. furthermore, women with pcos were reported with high risk of cardiovascular disease, the investigators planned to calculate the difference of carotid intima-media thickness (imt) and b-type natriuretic peptide (bnp) between women with pcos and normal control to determine the premature atherosclerosis of women with pcos.


Eligibility criteria:
inclusion criteria: * women at reproductive age * women with pcos and women without pcos. exclusion criteria: * young women who had their menarche less than 3 years * women older than 45 years old, amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis.
transcranial led therapy for severe acute traumatic brain injury

Conditions: Diffuse Axonal Brain Injury; Traumatic Brain Injury

Summary: the purpose of this study is to evaluate early and delayed effects of transcranial led therapy (tclt) and determinate whether this therapy is effective for cognitive rehabilitation of diffuse axonal injury patients after traumatic brain injury.

this is a randomized clinical trial of patient with diffuse axonal injury (dai) secondary to severe traumatic brain injury in its acute stage (less than 8h). it will be recruited thirty adult patients who will receive thirty minutes at three times per week for 6 weeks (18 sessions) of transcranial stimulation. fifteen of them will be stimulated with led helmet and the rest with a sham helmet identical to the led one, but only with a similar red light emission. patient who meet inclusion criteria will be assessed with glasgow outcome scale extended (gos-e) evaluation in at least five different periods (admission, before and after each stimulation, and at 3 and 6 months later in outpatient followup).

Eligibility criteria:
inclusion criteria: 1) patient victims of traumatic brain injury with glasgow coma scale ≤8 on admission: 1. head ct scan showing diffuse axonal lesion. 2. ct scan without focal surgical lesions (marshall i and ii) and no signs of intracranial hypertension. 3. transcranial doppler and optic nerve sheath us with no signs of intracranial hypertension. 4. admission less than 8 hours of trauma. exclusion criteria: 1. history of drug or narcotic abuse. 2. emergence of surgical lesions or signs of intracranial hypertension in followup cts. 3. transcranial doppler or optic nerve sheath us presenting signs of intracranial hypertension. 4. psychiatric disorders. 5. injury severity score ≥3, according to the abbreviated injury scale

Keywords: brain injuries, traumatic; diffuse axonal injury low-level light therapy neurologic manifestations quality of life rehabilitation
stereotactic radiation therapy in treating patients with brain metastases

Conditions: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. purpose: this phase ii trial is study how well stereotactic radiation therapy works in treating patients with brain metastases

objectives: primary * to determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases. secondary * to determine the overall survival rate at 6 months. * to determine the progression-free survival rate or brain metastases recurrence rate at 6 months. * to determine the time to neurological death, time to systemic death, and karnofsky decay time. * to determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy. outline: patients undergo conformal stereotactic radiotherapy over 5 days to an area including 3 mm around the metastases or the surgical cavity. patients may receive additional radiotherapy if symptomatic metastases emerge at different sites. after completion of study treatment, patients are followed up at 1 and 2 months and then every 3 months thereafter.

Eligibility criteria:
inclusion criteria: * histology-confirmed cancer with 1 to 3 symptomatic brain metastases imaged by mri/ct scans. * have cancer not originating in central nervous system (cns) * karnofsky score of at least 60 * given written consent * at least 18 years of age exclusion criteria: * prior whole brain radiotherapy or prior focal radiotherapy of the metastasis/es considered for this trial. * certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.

Keywords: tumors metastatic to brain unspecified adult solid tumor, protocol specific
study of cypass implantation in patients with open angle glaucoma refractory to single or multi-agent topical therapy

Conditions: Primary Open Angle Glaucoma (POAG)

Summary: the purpose of this study is to evaluate the safety and effectiveness of cypass implantation as a stand-alone therapy for lowering intraocular pressure (iop) in patients with primary open angle glaucoma (poag) who have failed at least one class of topical medical therapy


Eligibility criteria:
inclusion criteria: * diagnosis of poag * medicated iop ≥ 21 and ≤ 35 mmhg * use of 1 - 4 topical iop lowering medications exclusion criteria: * acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma * use of oral hypotensive medication treatment for glaucoma * previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure * clinically significant ocular pathology other than poag

Keywords: glaucoma glaucoma device glaucoma surgery intraocular pressure
ambulatory administration of meropenem with elastomeric pumps and an isothermal pouch

Conditions: Infection, Bacterial

Summary: this study aims to evaluate if meropenem can be administered in outpatients as a continuous infusion using elastomeric pumps and an isothermal pouch maintaining the anti-infective solution between 10° and 15°c for improved stability.

the outpatient parenteral antibiotic therapy (opat) unit of the university hospital of lausanne uses elastomeric pumps for continuous intravenous administration of 6 different antibiotics. this mode of administration is possible for all antibiotics with a time-dependent bactericidal effect. meropenem belongs to this class of antibiotics, but is not stable at room temperature in elastomeric pumps. however, this antibiotic is stable at 10°c and 15°c. the investigators have therefore developed an isothermal pouch that allows the anti-infective solution to be maintained at a temperature between 10 and 15°c over 24 hours. this study aims to evaluate the efficacy and safety of meropenem administration using an elastomeric pump maintained at a temperature between 10° and 15°c by an isothermal pouch. the possibility of being able to administer meropenem by elastomeric pumps would greatly facilitate the ambulatory management of patients requiring treatment with this anti-infective drug.

Eligibility criteria:
inclusion criteria: * patients referred to the opat unit for a anti-microbial treatment with meropenem * age ≥ 18 years * informed consent signed exclusion criteria: * patients refusing a picc-line * pregnancy or desire of a pregnancy * patients considered to be not eligible for outpatient treatment by the opat team

Keywords: meropenem outpatient parenteral antimicrobial therapy elastomeric pumps continuous infusion
efficacy and safety study for the treatment of dysfunctional uterine bleeding

Conditions: Metrorrhagia

Summary: the purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

this study has previously been posted by berlex, inc. berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc.bayer healthcare pharmaceuticals, inc.is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * women 18 years or older * with diagnosis of dysfunctional uterine bleeding without organic pathology * and with at least one of the following symptoms: prolonged, frequent, or excessive bleeding exclusion criteria: * the use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study. * women with history of endometrial ablation or dilatation or curettage within 2 months prior to study start will be excluded.

Keywords: dysfunctional uterine bleeding